Goralatide

Summary

Goralatide (N-acetyl-Ser-Asp-Lys-Pro; AcSDKP) is a naturally occurring tetrapeptide derived from thymosin beta-4 by prolyl oligopeptidase cleavage. It reversibly inhibits pluripotent hematopoietic stem cell proliferation, offering potential cytoprotection during myelosuppressive chemotherapy or radiotherapy. It has also been studied for antifibrotic properties in cardiac and renal fibrosis models. It has not received regulatory approval in any major jurisdiction.

Mechanism of Action

Goralatide (AcSDKP) is a naturally occurring tetrapeptide that inhibits the entry of pluripotent hematopoietic stem cells into the S-phase of the cell cycle, thereby protecting them from cytotoxic damage during chemotherapy or radiation. It acts as a negative regulator of hematopoietic stem cell proliferation.

Routes of Administration

Goals & Uses

• Reduction of cardiac fibrosisAntifibroticLow
• Myeloprotection during chemotherapyHematopoietic ProtectionModerate
• Reduction of renal fibrosisAntifibroticLow
• Radioprotection of bone marrowRadioprotectionModerate

Contraindications

• Hypersensitivity to goralatide or excipientsAllergyHigh

Adverse Effects

• Injection site reactionsLocalUncommon
• Transient myelosuppression risk if dosed incorrectlyHematologicRare

Drug Interactions

• Cytotoxic chemotherapy agentsLow
• ACE inhibitorsModerate

Population Constraints

• PregnancyReproductive SafetyRelative
• Pediatric populationsAgeRelative

Regulatory Status

• European UnionInvestigationalNo EMA approval. Subject of academic and preclinical research.
• United StatesInvestigationalNo FDA approval. Investigated in clinical trials as a myeloprotective agent.
• United KingdomUnknownNo known MHRA approval or regulatory submission identified.

Not approved by FDA, EMA, or MHRA. Investigated in clinical and preclinical settings primarily as a myeloprotective agent and antifibrotic compound. No approved therapeutic indication as of the available data.

Evidence & Sources

No sources recorded yet.